Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R 2) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma

Koji Izutsu, Yosuke Minami, Noriko Fukuhara, Yasuhito Terui, Tatsuro Jo, Go Yamamoto, Takayuki Ishikawa, Tsutomu Kobayashi, Toru Kiguchi, Hirokazu Nagai, Tomoko Ohtsu, Stacey Kalambakas, Pierre Fustier, Shuichi Midorikawa, Kensei Tobinai

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3 Citations (Scopus)

Abstract

Patients with indolent non-Hodgkin lymphoma (iNHL) typically respond to first-line immunochemotherapy, but relapse is common. Treatment options for relapsed iNHL include chemotherapy ± rituximab and rituximab monotherapy. Lenalidomide plus rituximab (R2) is an immunomodulatory regimen that enhances rituximab-mediated cytotoxicity and improves clinical activity in iNHL. AUGMENT was a double-blind phase III randomized trial of R2 vs. rituximab + placebo (R-placebo) in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma who were not refractory to rituximab. The primary endpoint was progression-free survival (PFS). Data reported here focus on Japanese patients from AUGMENT and reflect 36 patients (n = 18, each group). PFS was superior in the R2 group, HR = 0.32 (95% CI 0.11–0.96). Median PFS was not reached (95% CI 19.7–NE) in the R2 group vs. 16.5 months (95% CI 11.3–30.6) in the R-placebo group. Grade 3/4 adverse events were more frequent in patients treated with R2 (67%) than with R-placebo (22%), primarily attributable to increased neutropenia (50% vs 17%). R2 resulted in significantly longer median PFS than R-placebo in Japanese patients with R/R iNHL, and the efficacy and the safety profile of R2 were similar to those reported in the global population.

Original languageEnglish
Pages (from-to)409-416
Number of pages8
JournalInternational journal of hematology
Volume111
Issue number3
DOIs
Publication statusPublished - 2020 Mar 1

Keywords

  • Lenalidomide
  • Relapsed/refractory iNHL
  • Rituximab

ASJC Scopus subject areas

  • Hematology

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    Izutsu, K., Minami, Y., Fukuhara, N., Terui, Y., Jo, T., Yamamoto, G., Ishikawa, T., Kobayashi, T., Kiguchi, T., Nagai, H., Ohtsu, T., Kalambakas, S., Fustier, P., Midorikawa, S., & Tobinai, K. (2020). Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R 2) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma. International journal of hematology, 111(3), 409-416. https://doi.org/10.1007/s12185-019-02802-y